Pfizer to ship fewer vials of Covid-19 vaccine to account for ‘extra’ doses

But federal health officials who manage government contracts for syringes told the FDA that more than 70% of sites use the most effective syringes and more could be easily purchased or manufactured, another knowledgeable person said. of the situation.

Still, Pfizer’s attempts to pressure the FDA confused some health officials, especially since the company itself initially calculated that the vials contained five doses. If an extra dose could be extracted, it would mean that the vaccine supply could be stretched, thus protecting more Americans from the virus. On the other hand, too few special syringes would mean that the government could end up paying for wasted doses.

In early January, the debate was resolved after a “standard and customary legal review process,” an FDA spokeswoman said. On January 6, in an amendment to the emergency clearance, the FDA formally changed the vaccine data sheet to specify six doses.

“Syringes and / or low dead volume needles can be used to extract six doses from a single vial,” says the new US fact sheet. He also warned: “If standard syringes and needles are used, the volume may not be sufficient to extract a sixth dose from a single vial.”

In a statement, an FDA spokeswoman said the agency considered several factors in granting Pfizer’s request, including the availability of special syringes, the fact that other health authorities had made a similar decision. and that the change would immunize Americans faster.

Pfizer and the federal government have agreed to track which sites receive the syringes and other equipment needed to extract the extra dose, and that the company will not charge the United States for six doses per vial at sites that do not have this equipment. , according to a person familiar with the negotiations who was not allowed to speak because the talks are confidential.

As of next week, the number of Pfizer vaccines the federal government allocates to each state could be based on the assumption that each vial contains six doses, according to a federal official not authorized to discuss the matter. The CDC and the Department of Health and Human Services were discussing as recently as Friday afternoon when they might make the switch.